Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)

Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 2A and 2B)

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (<32.0° C) hypothermia in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

Study Overview

• Status: Completed
• Conditions: Preterm Infant; Hypothermia Neonatal
• Intervention / Treatment: Other: KMC & WHO protocol (0-1 hour); Other: KMC & WHO protocol (1-24 hours); Other: KMC, WHO protocol & bag (0-1 hour); Other: KMC, WHO protocol & bag (1-24 hours)

Detailed Description

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling) reduces the incidence of moderate hypothermia (32-36° C) or severe (<32.0° C) in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care, as practiced. The investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks and one for infants who are ≥37 weeks gestational age (this one). This term infant trial will address the effectiveness of KMC in combination with plastic bags in decreasing hypothermia in preterm infants. The proposed trial will determine whether KMC with plastic bags prevents hypothermia in neonates born in a healthcare setting with limited resources where a high risk for hypothermia has been reported. Any intervention that decreases morbidity during the neonatal period has the potential to impact health beyond the neonatal period,and one that is highly cost-effective and easy to use is more likely to be implemented in the developing world.

• Study Type: Interventional
• Enrollment (Actual): 423
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Estimated gestational age ≥37 0/7 weeks
• Delivery in the hospital

Exclusion Criteria:

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder
• Clinically unstable mothers secondary to cardiovascular and pulmonary conditions
• Infants requiring respiratory support beyond 10 minutes after birth
• Infant requiring Neonatal Intensive Care Unit admission
• Cesarean section
• Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: KMC & WHO protocol (0-1 hour); The combination of Kangaroo Mother Care (KMC) as continuously as possible together with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.	Other: KMC & WHO protocol (0-1 hour); WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
Active Comparator: KMC & WHO protocol (1-24 hours); The combination of Kangaroo Mother Care (KMC) as continuously as possible together with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.	Other: KMC & WHO protocol (1-24 hours); WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive
Experimental: KMC, WHO protocol & bag (0-1 hour); The combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.	Other: KMC, WHO protocol & bag (0-1 hour); In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag] linear low-density bag measuring 10 × 8 × 24 in. and 1.2 mil thick) that will cover the infant's torso and lower extremities.
Experimental: KMC, WHO protocol & bag (1-24 hours; The combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.	Other: KMC, WHO protocol & bag (1-24 hours); In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate or severe hypothermia at 1 hour after birth (Phase 2A)	Moderate (32.0-35.9C) or severe (<32.0C) hypothermia at 1 hour after birth (via axillary temperature)	1 hour after birth
Moderate or severe hypothermia at 24 hours or discharge (Phase 2B)	Moderate (32.0-35.9C) or severe (<32.0C) hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)	1 to 24 hours after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any hypothermia at 1 hour after birth (Phase 2A)	Any hypothermia (<36.5C) at 1 hour after birth	1 hour after birth
Any hypothermia at 1 hour after birth (Phase 2B)	Any hypothermia (<36.5C) at 24 hours or discharge, whichever occurs first	1 to 24 hours or discharge
Hyperthermia at 1 hour after birth (Phase 2A)	Hyperthermia (>38.0C) at 1 hour after birth	1 hour after birth
Hyperthermia at 1 hour after birth (Phase 2B)	Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first	1 to 24 hours or discharge
Skin rash	Skin rash (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Neonatal Intensive Care Unit admission	Neonatal Intensive Care Unit admission (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Respiratory distress syndrome	Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Sepsis	Diagnosis of sepsis (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Hypotension, hypoglycemia or seizure	Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Death	Death (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Maternal body temperature	Maternal body temperature in Celsius	At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first
Duration of KMC and plastic bag to infant's body temperature	Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius	During first 1 hour
Duration of KMC and plastic bag to infant's body temperature	Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius	During first 24 hours or discharge, or whichever occurs first]

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: University Teaching Hospital, Lusaka, Zambia

Publications and helpful links

General Publications

• Travers CP, Ramani M, Gentle SJ, Schuyler A, Brown C, Dills MM, Davis CB, Mwenechanya M, Chomba E, Aban I, Manasyan A, Ambalavanan N, Carlo WA. Early Skin-to-Skin Care with a Polyethylene Bag for Neonatal Hypothermia: A Randomized Clinical Trial. J Pediatr. 2021 Apr;231:55-60.e1. doi: 10.1016/j.jpeds.2020.12.064. Epub 2020 Dec 26.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2017
• Primary Completion (Actual): August 12, 2017
• Study Completion (Actual): August 12, 2017

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Infant; Hypothermia; Newborn; Preterm; Plastic; Kangaroo; Bag
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Body Temperature Changes; Premature Birth; Hypothermia
• Other Study ID Numbers: F150807003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No